Healthy Clinical Trial - Impact of Oral Contraceptives on GABA &

Status Terminated

Clinical Trial Summary

Thus, the proposed study has the following Specific Aims and Hypotheses:

1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl estradiol (EE) and the progestin ethinydiol diacetate (ED) increases cortical GABA concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above that of an OCP containing EE and the progestin norethindrone (NOR).

2. To determine the relationship between changes in occipital GABA concentrations with acute OCP administration and negative affect with chronic OCP administration over two menstrual cycles.

Clinical Trial Description

Approximately 11.6 million women in the United States use oral contraceptives (OCs) each year. The vast majority of OCs combine both estrogen and a type of progestin, or progesterone-like substance into one pill which is taken daily. Depression or a negative change in mood, apparently resulting from the use of OCs, is thought to be one of the main reasons women miss pills or stop taking their oral contraceptive pills (OCPs) altogether. Clinical observation that some women develop depression when taking progestin only OCs or when adding progestins to menopausal estrogen therapy has led to the speculation that the progestin is the likely culprit of these negative mood changes in women using combined OCPs.

The current study is designed to investigate the role of progestins in the development of mood symptoms in OCP users. Women participating in this study will receive one of two different OCPs for three months. Their mood while taking the OCPs will be compared to their mood prior to using OCPs. In addition, each woman will undergo a brain imaging study after the first dose of their OCP to determine whether acute changes in brain chemistry in response to the OCP predicts change in mood with OCP use. By choosing OCPs with the same estrogen product but 2 different types of progestins we hope to determine whether one type of progestin is more likely to result in negative mood.

Determining factors that contribute to the emergence of depression with OC use is the first step in developing newer oral contraceptives that do not have this health outcome and will ultimately improve compliance with OCP use. Reducing side effects of OCPs is likely to improve compliance and thus decrease the prevalence of unwanted pregnancy. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT00656318
Study type	Observational
Source	Yale University
Contact
Status	Terminated
Phase	N/A
Start date	August 2008
Completion date	March 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Impact of Oral Contraceptives on GABA and Neurosteroids

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms